Refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the year ended December 31, 2020 and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC's website at www.sec.gov. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Reporting by Takashi Umekawa in Tokyo, Silke Koltrowitz and John Miller in Zurich, Tamara Mathias and Arundhati Sarkar in Bengaluru; Editing by Sonali Paul and Emelia Sithole-Matarise. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie assumes no duty to update the information to reflect subsequent developments. Back-of-the-eye diseases, such as macular oedema, diabetic retinopathy and age-related macular degeneration, cause sight loss in millions of patients each year. Upload your resume . 2008;27(4):331-71. | Terms of use Over the next decade, major progress will be made in treating such retinal diseases and Allergan expects to be in the forefront of these advances. REGENXBIO is advancing research in two separate routes of administration of RGX-314 to the eye, through a standardized subretinal delivery procedure as well as delivery to the suprachoroidal space. It also helps deliver content-specific information to you and tracks how sections of websites are used. American Academy of Ophthalmology. | "AbbVie is a strong, complementary partner for REGENXBIO. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas. These press releases remain on AbbVie's website for historical purposes only. All quotes delayed a minimum of 15 minutes. Eye care professionals and patients can rely on Allergan products to treat a variety of eye conditions including glaucoma, dry eye, and external eye diseases. Today we are one of the global leaders in this specialty area and for the past six years have been one of the fastest-growing eye care companies worldwide. Join us and stay informed. The deal, announced early on Thursday, calls for $3.4 billion up front and milestone payments up to $1.9 billion, Novartis said. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. It is also the latest Japanese-European deal in the pharmaceutical sector following British drugmaker Astrazenecas $6.9 billion agreement in January to work with Daiichi Sankyo on an experimental breast cancer drug. Privacy policy AAO PPP. The Internet site that you have requested may not be optimized to your screen size. Cheung N, Mitchell P, Wong TY. The original site for employees in pharma, medical, diagnostic sales and related industries. Except as required by law, REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Find jobs. NORC at the University of Chicago: Chicago, Berrocal MD, Alexandra Acab. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate," "continue," "anticipate," "assume," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or by variations of such words or by similar expressions. Nature. and D.B. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients4. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery. A cookie can be used to enable a site to remember information that you previously input. Novartis shares were down 0.7 percent at 0812 GMT. Readers should not rely upon the information in these pages as current or accurate after their publication dates. AbbVie Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The recorded webcast will be available for approximately 30 days following the call. Current Management of Diabetic Retinopathy, 2018, Subscribe for email alerts Restores moisture, smooths fine lines and wrinkles; Reduces dark circles and puffiness; Lifts and firms the eyelid area; Free from fragrance, parabens, dyes, and mineral oil Alexandru MR, Alexandra NM. Br J Ophthalmol. DR affects approximately eight million people in the United States alone9. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS The acquisition from Takeda, which is jettisoning the medicine to reduce debt, adds to several big Novartis transactions over the last year as the Basel-based company both beefs up its portfolio and sheds non-core assets to focus on prescription drugs. Today we are one of the global leaders in this specialty area and for the past six . 2015;99:220. Before engaging, please read and adhere to our established community guidelines for each channel. REGENXBIO Forward-Looking StatementsThis press release includes "forward-looking statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. About RGX-314RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. 4-20-3 Ebisu. Novartis just shed its eyecare division Alcon into a separate publicly listed company in a $30 billion shareholder spin-off, but only after moving Alcons prescription eye drugs into Novartiss main pharmaceuticals business. Primary Care Sales Representative (Former Employee) - Orlando, FL - January 27, 2022. Company reviews. 2010;376(9735):12436. We may also use cookies to understand your preferences and tailor your access to your preferences. If you qualify, please. Prog Retin Eye Res. ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The forward-looking statements include statements relating to, among other things, REGENXBIO's proposed collaboration with AbbVie and REGENXBIO's future operations and clinical trials. Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. "We are committed to finding solutions for patients living with difficult-to-treat retinal diseases and to helping preserve and protect our patients from visual impairment and devastating vision loss," said Tom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. Under the terms of the agreement, AbbVie will pay REGENXBIO a $370 million upfront payment with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones. To access the live call by phone, dial (855) 422-8964 (domestic) or (210) 229-8819 (international) and enter the passcode 6379638. This lightweight, multifunctional eye cream is formulated to address the major signs of aging and fatigue. We look forward to leveraging our well-established commercial infrastructure to bring this medicine to more patients, said Paul Hudson, who heads Novartiss drugs business, adding the company sees Xiidra well positioned for blockbuster potential topping $1 billion annual sales. Rom J Ophthalmol. RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina1. At Allergan Aesthetics, we believe in the remarkable impact confidence can have on the lives, businesses, and careers of those we serve through our history as a company built on patient care, education and support of our customers, and our commitment to . Novartis is buying dry-eye drug Xiidra from Takeda Pharmaceutical Co for up to $5.3 billion as the Swiss drugmaker refreshes its ophthalmic medicines portfolio with a potential blockbuster. 1,003 reviews from Allergan employees about Allergan culture, salaries, benefits, work-life balance, management, job security, and more. Hada Labo Tokyo Age Correcting Eye Cream 0.5 Fluid Ounce . The "Yes" link below will take you out of the AbbVie family of websites. | Dugel PU, Koh A, Ogura Y, et al. To access a live or recorded webcast of the call, please visit the "Investors" section of the REGENXBIO website at www.regenxbio.com. These forward-looking statements speak only as of the date of this press release. "In collaboration with REGENXBIO, we aim to make a remarkable impact for the millions of patients suffering from vision loss associated with retinal diseases.". Cafepharma, Inc | 840 followers on LinkedIn. Unfortunately, the prevalence of these diseases is increasing as the population ages. Your consent is required for Allergan to remember your user details and preferences over time. Eye care professionals and patients can rely on Allergan products to treat a variety of eye conditions including glaucoma, dry eye, and external eye diseases. Carmeliet P. Angiogenesis in life, disease and medicine. Allergans websites may ask your browser to store cookies, a small piece of data, on your computer or mobile device. REGENXBIO has licensed certain exclusive rights to the SCS Microinjector from Clearside Biomedical, Inc. to deliver gene therapy treatments to the suprachoroidal space of the eye. Leading products in Allergan's eye care product portfolio include an implant to treat diabetic macular oedema, eye drops for glaucoma, OPTIVE Lubricant Eye Drops, and the REFRESH range of artificial tears. Sign up Sr Specialty Representative- Allergan Eye Care Tracy, California, United States 593 followers 500+ connections Join to follow Allergan California State University-East Bay About Presidents. NORTH CHICAGO, Ill. and ROCKVILLE, Md., Sept. 13, 2021 /PRNewswire/ --AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone3. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time7. See here for a complete list of exchanges and delays. Holz FG et al. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Current treatment options for patients with DR include "watchful waiting", anti-VEGF treatment, retinal laser or surgical treatment8. REGENXBIO shall participate in U.S. commercialization efforts as provided under a mutually agreed upon commercialization plan. Our robust research and development investment upholds our unwavering commitment to advancing eye care treatments. We are working to strategically simplify and optimize our portfolio, while also rapidly deleveraging, Takeda CEO Christophe Weber said in a statement. Rein. By checking "I accept," I authorize Allergan, or any contracted third parties acting on its behalf, to install cookies on my browser to remember the information that I input, track how I use sections of websites, enable Allergan to remember my user custom preferences, and to tailor my access to the website per my preferences. Shibuya-ku. Expected to close after July, the transaction includes 400 Takeda employees, which analysts from Bank Vontobel in Zurich said gives Novartis a marketing team to sell not only Xiidra but another prospective eye drug entrant, RTH258 for macular degeneration, now awaiting regulatory approval. About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. 2014. Subscription management. | Diabetic retinopathy. We also welcome the opportunity to hear from you in these social channels, but remember we work in a highly-regulated industry with unique legal considerations. Your consent is voluntary; however, if you do not consent to cookies being installed on your browser, Allergan may not be able to provide you full access to or all the functionality of our websites. If you consent, check I accept. You can withdraw your consent by changing your browser settings to erase cookies from your computers hard drive, block all cookies, or receive a warning before a cookie is stored. Following closing, we will explore the opportunity for the other territories acquired, a Novartis spokesman told Reuters. Cost of Vision Problems: The future of vision, forecasting the prevalence and costs of vision problems. 2019. Allergan is about discovering and developing new therapeutic agents to protect and preserve vision. Vascular endothelial growth factor in eye disease. ET. The information in the press releases on these pages was factually accurate on the date of publication. Generics maker Teva has a generic version of Restasis in Canada and is planning a launch in the United States, as is Mylan, pending resolution of legal disputes. Xiidra has yet to get European regulatory approval. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. About REGENXBIO Inc.REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. The transaction is expected to close by the end of 2021, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals. REGENXBIO and AbbVie will share equally in profits from net sales of RGX-314 in the U.S. AbbVie will pay REGENXBIO tiered royalties on net sales of RGX-314 outside the U.S. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. In addition, REGENXBIO will lead the manufacturing of RGX-314 for clinical development and U.S. commercial supply, and AbbVie will lead manufacturing of RGX-314 for commercial supply outside the U.S. YOU ARE ABOUT TO LEAVE FOR A 3RD PARTY WEBSITE. Test: /SEARCH /Widget-Documents Eye Care, If you have questions about the Company or request additional information, pleasecontact Allergan. Tokyo 150-6035 Japan. Xiidra, with $400 million in 2018 sales and approval in markets including the United States, Canada and Australia, competes with Allergans older Restasis. To access the live call by phone, dial (855) 422-8964 (domestic) or (210) 229-8819 (international) and enter the passcode 6379638. AbbVie will lead the clinical development and commercialization of RGX-314 globally. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. View our social media channel guidelines , AbbVie.com Follow @abbvieon Twitter, Facebook, Instagram, YouTubeand LinkedIn. This area is reserved for members of the news media. Cookie Settings. Allergan Japan KK. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. Copyright 2022 AbbVie Inc. North Chicago, Illinois, U.S.A. Wet age related macular degeneration management and follow-up. Xiidra, which treats signs and symptoms of dry eye by controlling inflammation, won U.S. regulatory approval in 2016 under Shires watch and was considered then its most important new medicine. However, whether actual results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties, including the anticipated completion of REGENXBIO's proposed transaction with AbbVie, the outcome of REGENXBIO's proposed collaboration with AbbVie and other factors, many of which are beyond the control of REGENXBIO. Our Standards: The Thomson Reuters Trust Principles. Yebisu Garden Place Tower 35F. Allergan is about discovering and developing new therapeutic agents to protect and preserve vision. For roughly 34 million U.S. dry eye sufferers, tears fail to adequately lubricate their eyes, and the condition can become painful, potentially leading to eye damage, Novartis said. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials. Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. TOKYO/ZURICH (Reuters) - Novartis is buying dry-eye drug Xiidra from Takeda Pharmaceutical Co for up to $5.3 billion as the Swiss drugmaker refreshes its ophthalmic medicines portfolio with a potential blockbuster. 2005;438:932-6. Ophthalmology. Wittenborn, J.S. For Takeda, this is its first divestment since its leveraged takeover of Shire in January, part of a flurry of multibillion-dollar pharmaceutical deals as drugmakers seek to buy other companies to combat expiring patents on their blockbuster medicines and renew their drug pipelines. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. The market (is) big enough for it to reach blockbuster status, justifying the price.. Penn JS, Madan A, Caldwell RB, et al. We expect to leverage AbbVie's global developmental and commercial infrastructure within eye care with our expertise in AAV gene therapy clinical development and deep in-house knowledge of manufacturing and production to continue the development of RGX-314," said Kenneth T. Mills, president and chief executive officer of REGENXBIO. - AbbVie and REGENXBIO form a strategic partnership combining eye care and gene therapy expertise. | The original site for . About RGX-314 Find salaries. 2016;60:913. Please check your Internet browsers instructions to learn more about these functions. About Diabetic RetinopathyDiabetic retinopathy (DR) is the leading cause of vision loss in adults between 24 and 75 years of age worldwide8. Site map The spectrum of DR severity ranges from non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) and as DR progresses, a large proportion of patients develop vision threatening complications, including diabetic macular edema (DME) and neovascularization that can lead to blindness10. Mutually agreed upon commercialization plan cookie can be used to enable a to! Aging and fatigue the date of this press release information to you tracks., double-masked trials of brolucizumab for neovascular age-related macular degeneration at www.regenxbio.com browser to store cookies a... Releases remain on AbbVie 's website for historical purposes only to access a or! About the company or request additional information, pleasecontact Allergan millions of patients each year in... These press releases remain on AbbVie 's website for historical purposes only take out..., Ogura Y, et al Age Correcting eye cream 0.5 Fluid.. 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